MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. IMPULSATOR; VENTILATOR

Device Problem Device Emits Odor (1425)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

As the end user experienced a drop in oxygen and required emergency service attention after using a percussionaire product, this incident is deemed reportable.After multiple attempts to obtain the product, percussionaire was unable to receive the product back for investigational purposes.Due to this, no root cause can be determined for this incident.No additional information has been received by the end user on patient status.If any additional information is received, a follow up mdr will be filed.

Event Description

Per complaint received from the customer, while providing treatment to the customer's child at home, the user smelled a burnt plastic smell coming from the device.Post treatment, the customer noticed their child's oxygen level dropped severly, requiring the need to call for emergency medical services.During a second treatment, occurring the following day, the customer noticed their child's oxygen level dropped again.No additional information has been received for this incident.

• Brand Name: IMPULSATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): PERCUSSIONAIRE CORP.; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer (Section G): PERCUSSIONAIRE CORP.; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer Contact: gina cunsolo ; 130 mcghee road; suite 109; sandpoint, ID 83864
• MDR Report Key: 18573321
• MDR Text Key: 333624278
• Report Number: 3029845-2024-00011
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00849436000389
• UDI-Public: 00849436000389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention